MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 5F DIGNITY CT PORT; DIGNITY® & PRO-FUSE® CT PLASTIC POWER INJECTABLE IMPLANTABLE

Model Number	MRDP50AXS
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	10/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Currently waiting for the return of the device.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
Patient had a 5fr port which had been implanted on (b)(6) 2024 and had been in place for 482 days for treatment.On (b)(6) 2025, port was to be accessed and it was observed by numerous rns that there appeared to be extravasation of fluids and the site was swollen.A dye study was ordered and performed on (b)(6) at 1236.During the dye study, access was achieved via huber needle but no blood return was noted, contrast was injected and it was demonstrated that the contrast was filling the port body and surrounding pocket but not entering the catheter.Patient was brought to sedation to have port removed on 10/10 in the afternoon and port was to be replaced.During removal, upon excision of the body of the port from the patient, it was observed that there is a pin hole in the back of the port body, through the printed t on the back.Port was replaced with same size and excised implant was saved for defect reporting.
Additional Manufacturer Narrative
The port was returned for evaluation with the lock collar and piece of lumen attached to the port body stem with a fibrin sheath surrounding the collar.The collar was removed but the lumen piece was left in place.Visual inspection confirmed the complaint as a hole can be seen in 't' engraved in the base of the port.Under magnification it was noted that the port base material was pushed outward from the reservoir.This is indicative of the needle being pushed through the port base, causing the material to be pushed outward.The contract manufacturer conducted a review of the manufacturing records.The review determined the device was manufactured within specifications and requirements.There were no abnormalities or non-conformance's associated with the lot number provided.There were no deviations, changes of materials, or process changes in the manufacturing of the part numbers.All inspections and sequences of operations were properly followed and documented.Work order passed qc final inspection.We are unable to determine the cause of this event.Excessive force may have been used when accessing the port.The health professional inserting the needle into the port may have misjudged the depth of the port and the amount of force necessary to access the port, causing the needle to go through the port base.

• Brand Name: 5F DIGNITY CT PORT
• Common Device Name: DIGNITY® & PRO-FUSE® CT PLASTIC POWER INJECTABLE IMPLANTABLE
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• Manufacturer Contact: susan smith ; 1499 delp drive; harleysville, PA 19438 ; 2152564201
• MDR Report Key: 23434973
• Report Number: 2518902-2025-00063
• Device Sequence Number: 4758957
• Product Code: LJT
• UDI-Device Identifier: 00884908149753
• UDI-Public: (01)00884908149753
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K132177
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Model Number: MRDP50AXS
• Device Catalogue Number: MRDP50AXS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/31/2025
• Supplement Report FDA Received Date: 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 4 YR
• Patient Sex: Female